MAUDE Adverse Event Report: WESTMED, INC. WESTMED VENTILATOR CIRCUIT; FILTER, BACTERIAL, BREATHING-CIRCUIT

Lot Number 031621U13

Device Problems Failure to Deliver (2338); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2021

Event Type  malfunction  

Event Description

Placed patient on mri transport circuit.The duckbill valve was closed and would not ventilate patient.I noticed the patient was not getting ventilated and placed the patient back on the pb840.

• Brand Name: WESTMED VENTILATOR CIRCUIT
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): WESTMED, INC.; 5580 s nogales hwy; tucson AZ 85706
• MDR Report Key: 15592567
• MDR Text Key: 301735605
• Report Number: 15592567
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 031621U13
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31755 DA
• Patient Sex: Female